Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients (EXAOS)

This study has been completed.

Sponsor:

Collaborator:

AGIR à Dom

Information provided by (Responsible Party):

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT00837018

First received: February 3, 2009

Last updated: March 4, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 3, 2009

Last Updated Date

March 4, 2013

Start Date ^ICMJE

June 2005

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Comparison of maximal oxygen consumption : OSAS patient versus control subjects. [ Time Frame: when the last patient realised the last visit ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00837018 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare physical exercise program to continuous positive airway pressure after 12 weeks of treatment in OSAS patients. [ Time Frame: when the last patient realised the last visit ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients

Official Title ^ICMJE

Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients: Cardiovascular and Metabolic Characterisation During Exercise. Treatments Effect.

Brief Summary

The syndrome of obstructive sleep apnea (OSAS) is a public health problem that affects 2 to 4% of the general population. The patients with OSAS frequently complain of intolerance to exercise muscle fatigue and a significant even if they have not been fully characterized in the literature.

The anomalies in the exercise of patients with OSAS could be due to metabolic changes (insulin resistance and oxidative stress) and cardiovascular (impaired vascular reactivity).

Our goal is both to determine whether these anomalies exist in patients with OSAS not obese, consider their relationship with the alteration of exercise capacity, and their reversibility in conventional PPC or by using the effects of physical activity regular.In this study Objectives: To establish whether the metabolic and vascular abnormalities associated with OSAS are associated with decreased parameters of physical fitness in relation to witnesses matched for age, sex and body mass index. Determine the effects of a re-training exercise on these parameters compared to the reference treatment, continuous positive pressure.

Main objective: To compare the exercise capacity of OSAS patients compared with that of witnesses matched for age, sex and body mass index.

Secondary objectives: To compare the effect of conventional treatment by continuous positive pressure (CPP) on cardiovascular and metabolic abnormalities of OSAS, with a therapeutic modality most original, physical activity.

Methodology: Test physiopathological parallel group, controlled, randomized.

Detailed Description

Study type : Physiopathology trial Study design : Prospective randomized controled trial

Expected Total Enrollment : 45 patients + 15 control subjects

Tested treatment : Physical exercise program (45 minutes, 3 times a week) Reference treatment : continuous positive airway pressure Treatment duration : 12 weeks (3 months) Total study duration : 2 years

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)

Condition ^ICMJE

Obstructive Sleep Apnea

Intervention ^ICMJE

Other: physical exercise program

45 min, 3times a week

Study Arm (s)

Experimental: Physical exercise program

45 min, 3 times a week

Intervention: Other: physical exercise program

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2012

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Ages Eligible for Study : 18 Years and above
Genders Eligible for Study: Both
Non obese : body mass index (BMI < 30 kg/m2)
Sedentary subjects : less physical activity than 30 minutes 3 time a week
and VOORIPS physical activity level questionnaire score < 9.

Obstructive sleep apnea syndrome (OSAS) patients :

Recently diagnosed (< 3 months)
AHI > 30 / hour (polysomnographic monitoring measurement)

Exclusion Criteria:

Excessive daytime sleepiness (Epworth score > 12)
Cardiovascular pathology (except controlled hypertension)
Pathology interacting with physical activity
Diabetes (known or treated)
Other participation to a clinical trial at the same

Gender

Both

Ages

40 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00837018

Other Study ID Numbers ^ICMJE

0520, DGS 2005/0312

Has Data Monitoring Committee

Responsible Party

University Hospital, Grenoble

Study Sponsor ^ICMJE

University Hospital, Grenoble

Collaborators ^ICMJE

AGIR à Dom

Investigators ^ICMJE

Principal Investigator:

Bernard Wuyam, doctor

CHU Grenoble

Information Provided By

University Hospital, Grenoble

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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